2474 Laboratories approved to perform blood lead and/or erythrocyte protoporphyrin determinations under the Clinical Laboratory Act
Laboratories Approved to Perform Blood Lead and/or Erythrocyte Protoporphyrin Determinations Under the Clinical Laboratory Act [36 Pa.B. 7688]
[Saturday, December 16, 2006]The following laboratories are licensed in accordance with the Clinical Laboratory Act (35 P. S. §§ 2151--2165) and/or the Federal Clinical Laboratory Improvement Act of 1967 (42 U.S.C. § 263a), and are currently approved under 28 Pa. Code § 5.50 (relating to approval to provide special analytical services) to perform analyses of blood for lead or erythrocyte protoporphyrin content. This approval is based on demonstrated proficiency in periodic evaluations conducted by the Bureau of Laboratories of the Department of Health.
Lead poisoning is a reportable noncommunicable disease. Approved laboratories which offer blood lead testing services are required to inform the Department of actual or possible incidents of this condition in accordance with 28 Pa. Code § 27.34 (relating to reporting cases of lead poisoning.) These regulations specify the following requirements for reporting by clinical laboratories.
(1) A clinical laboratory shall report all blood lead test results on both venous and capillary specimens for persons under 16 years of age to the Department's Childhood Lead Poisoning Prevention Program, Division of Maternal and Child Health, Bureau of Family Health.
(2) A clinical laboratory shall report an elevated blood lead level in a person 16 years of age or older to the Department's Division of Environmental Health Epidemiology, Bureau of Epidemiology or to other locations as designated by the Department. An elevated blood lead level is defined by the National Institute for Occupational Safety and Health (NIOSH). As of January 26, 2002, NIOSH defines an elevated blood lead level as a venous blood lead level of 25 micrograms per deciliter (µg/dL) or higher. The Department will publish in the Pennsylvania Bulletin any NIOSH update of the definition within 30 days of NIOSH's notification to the Department.
(3) A clinical laboratory which conducts blood lead tests on 100 or more specimens per month shall submit results electronically in a format specified by the Department.
(4) A clinical laboratory which conducts blood lead tests on less than 100 blood lead specimens per month shall submit results either electronically or by hard copy in the format specified by the Department.
(5) A laboratory which performs blood lead tests on blood specimens collected in this Commonwealth shall be licensed as a clinical laboratory and shall be specifically approved by the Department to conduct those tests.
(6) Blood lead analyses requested for occupational health purposes on blood specimens collected in this Commonwealth shall be performed only by laboratories which are licensed and approved as specified in paragraph (5), and which are also approved by the Occupational Safety and Health Administration of the United States Department of Labor under 29 CFR 1910.1025(j)(2)(iii) (relating to lead).
(7) A clinical laboratory shall complete a blood lead test within 5 work days of the receipt of the blood specimen and shall submit the case report to the Department by the close of business of the next work day after the day on which the test was performed. The clinical laboratory shall submit a report of lead poisoning using either the hard-copy form or electronic transmission format specified by the Department.
(8) When a clinical laboratory receives a blood specimen without all of the information required for reporting purposes, the clinical laboratory shall test the specimen and shall submit the incomplete report to the Department.
Erythrocyte protoporphyrin determinations may be performed as an adjunct determination to substantiate blood lead levels of 25 micrograms per deciliter or higher. Since erythrocyte protoporphyrin concentrations may not increase as a result of low-level exposures to lead, direct blood lead analysis is the only reliable method for identifying individuals with blood lead concentrations below 25 micrograms per deciliter.
Persons seeking blood lead or erythrocyte proto- porphyrin analyses should determine that the laboratory employs techniques and procedures acceptable for the purpose for which the analyses are sought. Laboratories offering blood lead analysis only are designated with the letter ''L'' following the name of the laboratory. Those offering erythrocyte protoporphyrin analysis only are designated with the letter ''P.'' Laboratories offering both services are designated with the letters ''LP.''
The list of approved laboratories will be revised approximately semiannually and published in the Pennsylvania Bulletin. The name of a laboratory is sometimes changed but the location, personnel and testing procedures of the facility remain unchanged. When changes of this type occur, the Clinical Laboratory Permit number does not change. If questions arise about the identity of a laboratory due to a name change, the Clinical Laboratory Permit number should be used as the primary identifier. To assist in identifying a laboratory that performed a test if the name of the facility changed, the Clinical Laboratory Permit numbers of the facilities are included in the lists of approved laboratories above the name of the laboratory at the time the list was prepared.
The Department's blood lead proficiency testing program is approved by the United States Department of Health and Human Services (HHS) in accordance with the requirements contained in the Clinical Laboratory Improvement Amendments of 1988 (42 CFR 493.901 and 493.937) which are administered by the Centers for Medicare and Medicaid Services (CMS). Participation in these programs may therefore be used to demonstrate acceptable performance for approval purposes under both Federal and Commonwealth statutes.
Questions regarding this list should be directed to Dr. M. Jeffery Shoemaker, Director, Division of Chemistry and Toxicology, Department of Health, Bureau of Laboratories, P. O. Box 500, Exton, PA 19341-0500, (610) 280-3464.
Persons with a disability who require an alternative format of this notice (for example, large print, audiotape, Braille) should contact Dr. Shoemaker at the previously referenced address or phone number. Persons who are speech or hearing impaired may call by using V/TT (717) 783-6514 or the Pennsylvania AT&T Relay Service at (800) 654-5984 (TT).
022912
ACL LABORATORIES--LP
8901 WEST LINCOLN AVE
WEST ALLIS, WI 53227
414-328-7945000016
ANGELINE KIRBY MEM HEALTH CENTER--L
71 NORTH FRANKLIN STREET
WILKES-BARRE, PA 18701
570-823-5450020506
CENTRAL PA ALLIANCE LABORATORY--LP
1803 MT ROSE AVENUE
SUITE C3-C4
YORK, PA 17403
717-851-1426000228
CHILDRENS HOSP OF PHILADELPHIA--L
ONE CHILDREN'S CENTER 34TH & CIVIC
PHILADELPHIA, PA 19104
215-590-1000027845
CLINICAL REFERENCE LABORATORY--LP
8433 QUIVIRA ROAD
LENEXA, KS 66215
913-492-3652000561
EAST PENN MFG CO INC--LP
DEKA RD KELLER TECH CENTER
PO BOX 147
LYONS STATION, PA 19536
610-682-6361000332
ELLWOOD CITY HOSPITAL--LP
724 PERSHING ST
ELLWOOD CITY, PA 16117
724-752-0081000173
GEISINGER MEDICAL CENTER--L
N ACADEMY RD
DANVILLE, PA 17822
570-271-6338025914
GENOVA DIAGNOSTICS--L
63 ZILLICOA STREET
ASHEVILLE, NC 28801
828-253-0621020802
HAGERSTOWN MEDICAL LABORATORY--L
11110 MEDICAL CAMPUS RD STE 230
HAGERSTOWN, MD 21742
301-790-8670024655
HEALTH NETWORK LABORATORIES--LP
2024 LEHIGH STREET
ALLENTOWN, PA 18103-4798
610-402-8150005618
LAB CORP OF AMERICA HOLDINGS--LP
6370 WILCOX ROAD
DUBLIN, OH 43016-1296
800-282-7300021885
LAB CORP OF AMERICA HOLDINGS--LP
1447 YORK COURT
BURLINGTON, NC 27215
800-334-5161001088
LABCORP OF AMERICA HOLDINGS--LP
69 FIRST AVE PO BOX 500
RARITAN, NJ 08869
908-526-2400009523
LABORATORY CORP OF AMERICA--L
13900 PARK CENTER ROAD
HERNDON, VA 20171
703-742-3100000242
MAIN LINE CLIN LABS LANKENAU CP--L
100 EAST LANCASTER AVENUE
WYNNEWOOD, PA 19096
610-645-2615029685
MAYO CLINIC DEPARTMENT OF LAB MEDICINE & PATHOLOGY--L
200 FIRST STREET SW
ROCHESTER, MN 55905
507-284-0453009003
MAYO CLINIC DEPT LAB MED & PATH--P
200 FIRST STREET
SW HILTON 530
ROCHESTER, MN 55905
507-284-3018029251
MAYO MEDICAL LABORATORIES NEW ENG LAND--LP
265 BALLARDVALE STREET
WILMINGTON, MA 01887
978-658-3600026302
MEDICAL ASSOCIATES PC--P
935 HIGHLAND BLVD SUITE 4400
BOZEMAN, MT 59715
406-587-5123005574
MEDTOX LABORATORIES INC--LP
402 WEST COUNTY ROAD D
ST PAUL, MN 55112
651-636-7466000203
MERCY FITZGERALD HOSPITAL--L
1500 LANSDOWNE AVENUE
DARBY, PA 19023
610-237-4262000504
NATIONAL MED SVCS INC/DBA NMS LABS--LP
3701 WELSH ROAD
WILLOW GROVE, PA 19090
215-657-4900023801
PACIFIC TOXICOLOGY LABORATORIES--LP
9348 DE SOTO AVENUE
CHATSWORTH, CA 91311
818-598-3110022533
PENNSYLVANIA DEPT OF HEALTH--LP
110 PICKERING WAY
LIONVILLE, PA 19353
610-280-3464000022
POCONO MEDICAL CENTER LAB--L
206 EAST BROWN STREET
EAST STROUDSBURG, PA 18301
570-476-3544000324
PRIMARY CARE HLTH SERV INC LAB--L
7227 HAMILTON AVE
PITTSBURGH, PA 15208
412-244-4728000255
PUBLIC HEALTH LAB CITY OF PHILA--L
500 SOUTH BROAD STREET
ROOM 359
PHILADELPHIA, PA 19146
215-685-6815022715
QUEST DIAGNOSTICS--LP
10101 RENNER BOULEVARD
LENEXA, KS 66219-9752
913-888-1770000315
QUEST DIAGNOSTICS CLINICAL LABS INC--LP
900 BUSINESS CENTER DRIVE
HORSHAM, PA 19044
215-957-9300000669
QUEST DIAGNOSTICS INCORPORATED--L
ONE MALCOLM AVENUE
TETERBORO, NJ 07608
201-393-5602001136
QUEST DIAGNOSTICS NICHOLS INSTITUTE--LP
14225 NEWBROOK DRIVE
P. O. BOX 10841
CHANTILLY, VA 20153-0841
703-802-6900000482
QUEST DIAGNOSTICS OF PA INC--LP
875 GREENTREE ROAD
4 PARKWAY CENTER
PITTSBURGH, PA 15220-3610
412-920-7600025461
QUEST DIAGNOSTICS VENTURE LLC--LP
875 GREENTREE ROAD
4 PARKWAY CENTER
PITTSBURGH, PA 15220-3610
412-920-7631000150
READING HOSPITAL & MED CTR--L
6TH AND SPRUCE STREETS
WEST READING, PA 19611
610-988-8080022376
SPECIALTY LABORATORIES INC--L
27027 TOURNEY ROAD
VALENCIA, CA 91355
661-799-6543000151
ST JOSEPH QUALITY MEDICAL LAB--L
2500 BERNVILLE ROAD
READING, PA 19605-9453
610-378-2200000104
THE UNIONTOWN HOSPITAL LABORATORY--L
500 WEST BERKELEY STREET
UNIONTOWN, PA 15401
724-430-5143000083
UPMC PRESBYTERIAN SHADYSIDE CP PUH--L
ROOM 5929 MAIN TOWER CHP
200 LOTHROP STREET
PITTSBURGH, PA 15213-2582
412-648-6000CALVIN B. JOHNSON, M. D., M.P.H.,
Secretary[Pa.B. Doc. No. 06-2474. Filed for public inspection December 15, 2006, 9:00 a.m.]
